Peter Dizikes’s picture

By: Peter Dizikes

Given the complexities of healthcare, do basic statistics used to rank hospitals really work well? A study co-authored by MIT economists indicates that some fundamental metrics do, in fact, provide real insight about hospital quality.

“The results suggest a substantial improvement in health if you go to a hospital where the quality scores are higher,” says Joseph Doyle, an MIT economist and co-author of a new paper detailing the study’s results.

The study was designed to work around a difficult problem in evaluating hospital quality: Some high-performing hospitals may receive an above-average number of very sick patients. Accepting those difficult cases could, on the surface, worsen the aggregate outcomes of a given hospital’s patients and make such hospitals seem less effective than they are.

However, the scholars found a way to study equivalent pools of patients, thus allowing them to judge the hospitals in level terms. Overall, the study shows, when patient sickness levels are accounted for, hospitals that score well on quality measures have 30-day readmission rates that are 15 percent lower than a set of lesser-rated hospitals, and 30-day mortality rates that are 17 percent lower.

Anne Trafton’s picture

By: Anne Trafton

After a patient has a heart attack or stroke, doctors often use risk models to help guide their treatment. These models can calculate a patient’s risk of dying based on factors such as the patient’s age, symptoms, and other characteristics.

While these models are useful in most cases, they do not make accurate predictions for many patients, which can lead doctors to choose ineffective or unnecessarily risky treatments for some patients.

“Every risk model is evaluated on some dataset of patients, and even if it has high accuracy, it is never 100-percent accurate in practice,” says Collin Stultz, a professor of electrical engineering and computer science at MIT and a cardiologist at Massachusetts General Hospital. “There are going to be some patients for which the model will get the wrong answer, and that can be disastrous.”

Stultz and his colleagues from MIT, IBM Research, and the University of Massachusetts Medical School have now developed a method that allows them to determine whether a particular model’s results can be trusted for a given patient. This could help guide doctors to choose better treatments for those patients, the researchers say.

Kelvin Lee’s picture

By: Kelvin Lee

Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes, and autoimmune disorders. Manufacturing medicine using biology presents different challenges from the traditional chemical manufacturing processes that stamp out identical pressed pills.

Biomanufacturing processes are hard to control, and the products are difficult to define as “identical” from batch to batch. Despite these challenges, biopharmaceuticals are critical to public health because the advantages are significantly greater. Scientific understanding of diseases and the success of biologically manufactured therapies to treat them has increased dramatically. But it can take a decade from design to full production of a biopharmaceutical—not fast enough to meet the needs of all the patients, or to beat competition from overseas.

Clinton Ballew’s picture

By: Clinton Ballew

Legislative support is growing for the reimbursement of care delivery via telemedicine. The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General have recently made final and proposed rule changes to stimulate greater use and access for telemedicine delivery. These changes mean that for healthcare providers all around the United States, telemedicine will become a greater strategic focus.

Three major areas of telemedicine affected are remote patient monitoring (RPM) services, chronic care management (CCM), and opioid use disorder (OUD) treatment. Here we highlight the most significant changes that will impact providers in 2020 and beyond.

Remote patient monitoring (RPM)

Until recently, this contributing technology for telemedicine has been hampered by murky details within existing law. It is now, however, the area of the industry experiencing the most significant changes in recent rulemaking.

Quality Digest’s default image

By: Quality Digest

As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and this year was no different.

Below are five articles that garnered a lot of interest from our readers. As you can see, the topics are quite diverse.

Improve Risk Management and Quality Across the Value Chain by Increasing Visibility
by Kelly Kuchinski

Anat Amit-Eyal’s picture

By: Anat Amit-Eyal

Eric, a 40-something married father of three, runs a successful startup. Given his demanding career, he and his wife decided she would be a stay-at-home mum. Eric believed the attention he devoted to his family was adequate, and that he had fully harmonized his work as CEO and life as a family man.

On a recent family trip, Eric continued working as much as he could, as he always did. While taking a conference call, he dropped his phone and, without hesitation, leapt to catch it at the risk of hurting himself. Seeing this, his 13-year-old son blurted out, “I don’t know if you would have jumped after me like that.” Only then did Eric realize that his son didn't think he prioritized their family. Eric had been oblivious that his family felt neglected; he had been unaware or was in denial.

Michael Millenson’s picture

By: Michael Millenson

In late November 1999, a TV producer called me about an alarming report that 44,000 to 98,000 Americans were being killed each year by preventable errors in hospitals, and another 1 million were being injured. Could that be true? Based on my research, I replied, the estimate seemed low.

The “To Err is Human” report from the Institute of Medicine has been called a “seminal moment” in the patient safety fight. The public furor sparked by the group’s assertion that medical mistakes were deadlier than breast cancer, auto accidents, or AIDS prompted new laws, as well as vows to meet the Institute of Medicine’s goal of cutting medical errors in half in five years.

Twenty years after the report’s release, how safe is our medical care?

The QA Pharm’s picture

By: The QA Pharm

Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups.

Also, each quiz will have one letter tile at the bottom. Collect all eleven tiles and unscramble the letters for an important message.

When you have completed all 11 quizzes, you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training. Be sure to document this training according to your established procedures.

An answer key will be provided after the eleventh quiz to use for further discussion.

 

Heather Thompson’s picture

By: Heather Thompson

Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.

Medical device companies developing these products can take advantage of the FDA’s new programs designed to advance trusted companies so they can get products to market efficiently and effectively.

Equally important, if you want to be part of the SaMD trend and its accompanying regulatory pathway, the FDA is clear: Make sure your quality management system (QMS) is exemplary.

Steve Hawk’s default image

By: Steve Hawk

The company Grace Science was born through an inversion of the normal business sequence. Typically, if an entrepreneur launches a startup and it succeeds, the founders will create a nonprofit, declaring, “We want to give back.” In this case, the nonprofit spawned the startup.

The company’s inception accelerated when Matt Wilsey first met with Carolyn Bertozzi in 2015. Bertozzi is the Anne T. and Robert M. Bass Professor of Chemistry and professor of chemical and systems biology and of radiology (by courtesy) at Stanford University.

Wilsey’s daughter, Grace, has an ultra-rare disorder caused by a mutation in a gene known as NGLY1. Only 54 people in the world have been diagnosed with the disease. In 2014, Wilsey and his wife, Kristen, created a nonprofit, the Grace Science Foundation, in their quest to find a cure. The foundation has raised about $9 million to date.

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